ABSTRACT
BACKGROUND & AIMS: Despite therapeutic advances, effective treatments for chronic constipation remain an unmet need. The vibrating capsule is a nonpharmacologic, orally ingested, programmable capsule that vibrates intraluminally to induce bowel movements. We aimed to determine the efficacy and safety of the vibrating capsule in patients with chronic constipation. METHODS: We conducted a phase 3, double-blind, placebo-controlled trial of patients with chronic constipation, who were randomized to receive either a vibrating or placebo capsule, once daily, 5 days a week for 8 weeks. The primary efficacy end points were an increase of 1 or more complete spontaneous bowel movements per week (CSBM1 responder) or 2 or more CSBMs per week (CSBM2) from baseline during at least 6 of the 8 weeks. Safety analyses were performed. RESULTS: Among 904 patients screened, 312 were enrolled. A greater percentage of patients receiving the vibrating capsule achieved both primary efficacy end points compared with placebo (39.3% vs 22.1%, P = .001 for CSBM1; 22.7% vs 11.4% P = .008 for CSBM2). Significantly greater improvements were seen with the vibrating capsule for the secondary end points of straining, stool consistency, and quality-of-life measures compared with placebo. Adverse events were mild, gastrointestinal in nature, and similar between groups, except that a mild vibrating sensation was reported by 11% of patients in the vibrating capsule group, but none withdrew from the trial. CONCLUSIONS: In patients with chronic constipation, the vibrating capsule was superior to placebo in improving bowel symptoms and quality of life. The vibrating capsule was safe and well tolerated. (Clinical trials.gov, Number: NCT03879239).
Subject(s)
Constipation , Quality of Life , Humans , Constipation/diagnosis , Constipation/drug therapy , Defecation , Treatment Outcome , Double-Blind MethodABSTRACT
Background: Coronavirus disease 2019 (COVID-19) can lead to ventilator-dependent chronic respiratory failure and a need for tube feeding. Percutaneous endoscopic gastrostomy (PEG) placement provides more sustainable longer-term enteral access with fewer side effects compared to the long-term nasogastric tube placement. Bleeding is a recognized complication of PEG placement, and many COVID-19 patients are on antiplatelets/anticoagulants, yet minimal data exist on the safety of PEG tube placement in this context. Methods: A retrospective chart review identified patients who underwent PEG placement between January 2020 and January 2021 at a single institution. Success was defined as PEG placement and use to provide enteral nutrition with no complications requiring removal within 4 weeks. Results: Thirty-six patients with and 104 age- and sex-matched patients without COVID-19 infection were included. More COVID-19 patients were obese, on anticoagulants, had low serum albumin levels and had a tracheostomy in place. Of those patients, 8.3% with COVID-19 developed PEG-related complications compared to 16.3% without (P = 0.28). PEG success rates in patients with and without COVID-19 were similar at 97.2% and 92.3%, respectively (P = 0.44). Conclusion: PEG tube placement is comparatively safe in COVID-19 patients who need long-term enteral access.
Subject(s)
COVID-19/prevention & control , Colonic Neoplasms/diagnosis , Colonic Neoplasms/prevention & control , Early Detection of Cancer , Health Care Rationing , Health Services Accessibility , Infection Control , COVID-19/epidemiology , Colonic Neoplasms/epidemiology , Colonoscopy/standards , Early Detection of Cancer/methods , Early Detection of Cancer/standards , Global Health , Health Care Rationing/methods , Health Care Rationing/organization & administration , Health Services Accessibility/organization & administration , Humans , Infection Control/methods , Infection Control/organization & administration , Pandemics , Practice Guidelines as Topic , United States/epidemiologyABSTRACT
The available COVID-19 literature has focused on specific disease manifestations, infection control, and delivery or prioritization of services for specific patient groups in the setting of the acute COVID-19 pandemic. Local health systems aim to contain the COVID-19 pandemic and hospitals and health-care providers rush to provide the capacity for a surge of COVID-19 patients. However, the short, medium-term, and long-term outcomes of patients with gastrointestinal (GI) diseases without COVID-19 will be affected by the ability to develop locally adapted strategies to meet their service needs in the COVID-19 setting. To mitigate risks for patients with GI diseases, it is useful to differentiate three phases: (i) the acute phase, (ii) the adaptation phase, and (iii) the consolidation phase. During the acute phase, service delivery for patients with GI disease will be curtailed to meet competing health-care needs of COVID-19 patients. During the adaptation phase, GI services are calibrated towards a "new normal," and the consolidation phase is characterized by rapid introduction and ongoing refinement of services. Proactive planning with engagement of relevant stakeholders including consumer representatives is required to be prepared for a variety of scenarios that are dictated by thus far undefined long-term economic and societal impacts of the pandemic. Because substantial changes to the delivery of services are likely to occur, it is important that these changes are embedded into quality and research frameworks to ensure that data are generated that support evidence-based decision-making during the adaptation and consolidation phases.